510(k) · Cleared
ClearedDeroyal Non-Locking Bone Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deroyal Industries, Inc. · HRS Plate, Fixation, Bone
Cleared on Apr 12, 2010 after a 371-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 12, 2010
- Review
- 371 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The DeRoyal Non-Locking Bone Fixation System components are provided non-sterile. The system is intended to treat fractures of various bones, including the clavicle, scapula, long bones, (humerus, ulna, radius, femur, tibia and fibula), small bones (metacarpals, metatarsals, and phalanges). A Screw-Plate Usage Chart is included to assist the user in selection of the appropriate screws for recommended use with each plate. Cannulated screws included in…
Read the full statement (199 words)
The DeRoyal Non-Locking Bone Fixation System components are provided non-sterile. The system is intended to treat fractures of various bones, including the clavicle, scapula, long bones, (humerus, ulna, radius, femur, tibia and fibula), small bones (metacarpals, metatarsals, and phalanges). A Screw-Plate Usage Chart is included to assist the user in selection of the appropriate screws for recommended use with each plate.
Cannulated screws included in this bone fixation system are not designed to be used with specific plates. They can be used as a stand alone fracture fixation; or in the case of compromised bone stock, they can be used in conjunction with washers.
The washer components are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces I load over a larger area when used for fracture fixation of large (long) bone and bone fragments. Additionally, the washers are intended to prevent the projection of the screw head when the screw must be inserted at an acute angle such as in ankle arthrodesis.
The wires in this system are for use in the fixation of bone fractures, for bone reconstruction or as a guide for insertion of other medical devices.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K090975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090975: Deroyal Non-Locking Bone Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090975
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026